紫杉醇脂质体联合顺铂方案一线治疗晚期非小细胞肺癌的临床随机对照研究

BACKGROUND AND OBJECTIVE: Paclitaxel plus cisplatin (TP) is used as the standard regimen for patients with advanced non-small cell lung cancer (NSCLC). In this study, we compared the response rate (RR), overall survival (OS), and toxicity of the combined chemotherapy regimen of liposomal paclitaxel plus cisplatin (LP) with those of TP as first-line treatments for advanced NSCLC. METHODS: A total of 100 patients were randomly selected to be treated with liposomal paclitaxel or paclitaxel at a dose of 150 mg/m(2) on day 1 plus cisplatin at a dose of 75 mg/m(2) on days 1 and 2 per cycle every 21 days. RESULTS: All 100 patients were eligible. The median progression free survival was 5.1 months vs 4.2 months, the median OS was 9.0 months vs 9.3 months, and RR was 26% vs 24% in the LP and TP arms, respectively. No significant difference was observed (P=0.110, 0.342 and 0.890, respectively). There was no significant difference between grades 3 and 4 toxicity of the arms (P > 0.05). Peripheral neuritis observed in the LP arm was significantly lower than that in the TP arm (8% vs 28%), and the difference was statistically significant (P=0.030). CONCLUSION: The effects of LP and TP as first-line therapies for NSCLC are similar. However, peripheral neuritis in the LP arm is significantly lower than in the TP arm.